Application 207219
- Type
- ANDA
- Sponsor
- YAOPHARMA CO LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | No | No |
| 002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 30MG BASE | No | No |
| 003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 60MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A207219-001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | ||
| A207219-002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | ||
| A207219-003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-08-16 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-08-16 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | AB | 2019-08-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A207219-003 | DULOXETINE HYDROCHLORIDE | EQ 60MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207219-001 | DULOXETINE HYDROCHLORIDE | EQ 20MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A207219-002 | DULOXETINE HYDROCHLORIDE | EQ 30MG BASE | CAPSULE, DELAYED REL PELLETS / ORAL | 2019-08-16 | c0c555d07b60… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A207219-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207219-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A207219-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A207219-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207219-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A207219-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A207219-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207219-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A207219-003 | AB | 1 | b00525d2431f… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | 90224073-178d-7ec5-e053-2995a90a20fc | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | 207219 ANDA207219 50771-201 50771-202 50771-203 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50771-201 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-201 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-202 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-202 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-203 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | ANDA | Current |
| 50771-203 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | Yaopharma Co., Ltd. | ANDA | Current |